Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 19057-19058 [2017-08299]

Download as PDF 19057 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices estimated burden. This burden estimate assumes that there are approximately 2,520 IRBs, that each IRB meets on an average of 14.6 times annually, and that approximately 100 hours of person-time per meeting are required to meet the requirements of the regulation. In the Federal Register of November 1, 2016 (81 FR 75826), we published a 60-day notice requesting public comment on the proposed extension of this collection of information. No comments were received in response to the notice. FDA estimates the burden of this collection as follows: TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 21 CFR part 56; subpart D; records and reports Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours 56.115 .................................................................................. 2,520 14.6 36,792 100 3,679,200 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08327 Filed 4–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA 2017–N–1780] Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of meeting; establishment of a public docket, request for comments. ACTION: The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Pediatric Advisory Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The general function of the committees is to provide advice and make recommendations to the Agency on pediatric ethical issues. The meeting will be open to the public. FDA is establishing a docket for public comments on this document. DATES: The meeting will be held on May 18, 2017, from 8:30 a.m. to 5:30 p.m. The docket number is FDA 2017–N– 1780. The docket will close on May 19, 2017. Comments received on or before May 5, 2017 will be provided to the committee. Comments received after the date will be taken into consideration by the Agency. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 MD 20993–0002. For those unable to attend in person, the meeting will also be webcast. The link for the webcast is available at https:// collaboration.fda.gov/pacm051817. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm408555.htm. You may submit your comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to make available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submission as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA 2017– N–1780 for the ‘‘Joint Meeting of the Pediatric Advisory Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this E:\FR\FM\25APN1.SGM 25APN1 asabaliauskas on DSK3SPTVN1PROD with NOTICES 19058 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240–402–3838, email: marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. Scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On May 18, 2017, the PAC and the PES will meet to discuss a referral by an Institutional Review Board (IRB) of a clinical investigation that involves children and FDA regulated products. The clinical investigation is entitled ‘‘A DoubleBlind, Placebo-Controlled, Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP– 4045 and SRP–4053 in Patients with Duchenne Muscular Dystrophy.’’ Comments about the upcoming joint meeting should be submitted to Docket No. FDA 2017–N–1780. After presentation of an overview of the IRB referral process under 21 CFR 50.54, an overview of the protocol and the issues raised by the IRB referral, other relevant presentations about the request to modify the protocol, and a VerDate Sep<11>2014 17:42 Apr 24, 2017 Jkt 241001 summary of the public comments received concerning whether the protocol should proceed as modified, the committee will discuss the protocol modification and develop a recommendation regarding whether the protocol should proceed as modified. The committee’s recommendation will then be presented to the Commissioner of Food and Drugs. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material will be available at: https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before May 11, 2017. Oral presentations from the public will be scheduled on May 18, 2017 between approximately 11 a.m. and 12:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 3, 2017. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 4, 2017. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Marieann Brill PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–08299 Filed 4–24–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2005–N–0464 (Formerly Docket No. 2005N–0403)] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution and Blood Establishment Registration and Product Listing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that two collections of information: ‘‘Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution’’ and ‘‘Blood Establishment Registration and Product Listing’’ have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796– 3794. SUMMARY: On December 16, 2016, the Agency submitted proposed collections of information entitled ‘‘Establishment Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution’’ and ‘‘Blood Establishment Registration and Product Listing’’ to SUPPLEMENTARY INFORMATION: E:\FR\FM\25APN1.SGM 25APN1

Agencies

[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19057-19058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA 2017-N-1780]


Joint Meeting of the Pediatric Advisory Committee and the 
Pediatric Ethics Subcommittee; Notice of Meeting; Establishment of a 
Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting; establishment of a public docket, request 
for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) announces a 
forthcoming public advisory committee meeting of the Pediatric Advisory 
Committee (PAC) and the Pediatric Ethics Subcommittee (PES). The 
general function of the committees is to provide advice and make 
recommendations to the Agency on pediatric ethical issues. The meeting 
will be open to the public. FDA is establishing a docket for public 
comments on this document.

DATES: The meeting will be held on May 18, 2017, from 8:30 a.m. to 5:30 
p.m. The docket number is FDA 2017-N-1780. The docket will close on May 
19, 2017. Comments received on or before May 5, 2017 will be provided 
to the committee. Comments received after the date will be taken into 
consideration by the Agency.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 
Conference Center, the Great Room (Rm. 1503, section A), Silver Spring, 
MD 20993-0002. For those unable to attend in person, the meeting will 
also be webcast. The link for the webcast is available at https://collaboration.fda.gov/pacm051817. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at 
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    You may submit your comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to make available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submission as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA 2017-N-1780 for the ``Joint Meeting of the Pediatric Advisory 
Committee and the Pediatric Ethics Subcommittee; Notice of Meeting; 
Establishment of a Public Docket; Request for Comments.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this

[[Page 19058]]

information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marieann Brill, Office of the 
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5154, Silver Spring, MD 20993, 240-402-3838, email: 
marieann.brill@fda.hhs.gov, or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in 
the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm. Scroll down to the appropriate advisory 
committee meeting link, or call the advisory committee information line 
to learn about possible modifications before coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On May 18, 2017, the PAC and the PES will meet to discuss a 
referral by an Institutional Review Board (IRB) of a clinical 
investigation that involves children and FDA regulated products. The 
clinical investigation is entitled ``A Double-Blind, Placebo-
Controlled, Multi-Center Study with an Open-Label Extension to Evaluate 
the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with 
Duchenne Muscular Dystrophy.'' Comments about the upcoming joint 
meeting should be submitted to Docket No. FDA 2017-N-1780.
    After presentation of an overview of the IRB referral process under 
21 CFR 50.54, an overview of the protocol and the issues raised by the 
IRB referral, other relevant presentations about the request to modify 
the protocol, and a summary of the public comments received concerning 
whether the protocol should proceed as modified, the committee will 
discuss the protocol modification and develop a recommendation 
regarding whether the protocol should proceed as modified. The 
committee's recommendation will then be presented to the Commissioner 
of Food and Drugs.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material will be 
available at: https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
11, 2017. Oral presentations from the public will be scheduled on May 
18, 2017 between approximately 11 a.m. and 12:30 p.m. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit a brief statement of the general nature of 
the evidence or arguments they wish to present, the names and addresses 
of proposed participants, and an indication of the approximate time 
requested to make their presentation on or before May 3, 2017. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by May 4, 2017.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
disabilities. If you require accommodations due to a disability, please 
contact Marieann Brill at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08299 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P

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